Nicotine dependence is increasingly recognized as a complex and chronic condition. Only 10-20% of smokers receiving smoking-cessation interventions are able to maintain abstinence for 1 year. Poor outcomes from smoking-cessation programs may be due to the brevity and limited intensity of most existing behavioral treatments that supplement pharmacologic treatment. In our laboratory we have found very low quit rates (14%) for smokers given intensive, high-dose individualized nicotine patch therapy accompanied by only very minimal behavioral counseling. We are proposing a study that will examine, using a randomized, carefully-controlled experimental design, whether use of extended-duration counseling protocols of moderate intensity will significantly improve cessation rates. Our study will provide the first information to our knowledge regarding the optimal duration of counseling needed to maximize cessation rates among those receiving nicotine replacement treatment. We will recruit a sample of 450 smokers and provide nicotine patch treatment for 12 weeks. Subjects will be randomly assigned to one of the following post-quit counseling conditions: (A) 12 weeks, (B) 24 weeks, or (C) 52 weeks of counseling. Our study will provide a replication and significant extension of the recent seminal work of Hall et al. (Hall et al., Am J Psychiatry 2004;161:2100-2107) that found, in a small sample, that an extended counseling protocol of 52 weeks duration produced 1-year quit rates of 50-55%. We will determine whether use of extended-duration counseling protocols can obtain similar quit rates at 1 year post-cessation among a large, representative sample of more heavily-dependent smokers. We will also determine whether a 52-week treatment protocol is necessary to produce optimal cessation rates, or whether a shorter-duration treatment (6 months), perhaps more acceptable to smokers, might be as effective, or nearly as effective. In addition, we will examine mechanisms (e.g., social support) through which extended duration counseling may increase cessation rates, and follow smokers for 2 years to assess the durability of the assumed higher quit rates at year 1 among those randomized to the more extended duration counseling conditions. Secondary aims will examine whether extended duration counseling may be especially beneficial for certain subgroups such as women, those of lower education, and those with depressive symptoms. We will also provide information on the difficulties that smokers experience at different post-cessation periods of the quit attempt which may be useful for the development of future time-specific treatment interventions. If our prime hypothesis concerning the efficacy of extended-duration counseling is supported, this would suggest that a new treatment model, involving more frequent and structured contact, longer periods of observation, and renewed quit attempts in the event of relapse, may be necessary to reduce the prevalence of cigarette smoking among the increasingly recalcitrant population of smokers in the United States. Project Narrative Relapse (return to smoking) occurs for the majority of smokers (approximately 80-95%) who try to quit. Our study will test the efficacy of using an extended-duration counseling procedure for improving long-term cessation outcomes among more heavily-dependent smokers. The ultimate goal of this line of research is to develop treatments that will increase the likelihood that smokers will succeed in their quit attempts.
|Mustonen, Taru Kinnunen; Spencer, Stacie M; Hoskinson, Randall A et al. (2005) The influence of gender, race, and menthol content on tobacco exposure measures. Nicotine Tob Res 7:581-90|